This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | PROSORBA(TM) COLUMN |
| Generic Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
| Applicant | FRESENIUS HEMOCARE, INC. |
| Date Received | 1985-04-02 |
| Decision Date | 1987-12-23 |
| Notice Date | 1988-02-23 |
| PMA | P850020 |
| Supplement | S |
| Product Code | MDP |
| Docket Number | 88M-0019 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | FRESENIUS HEMOCARE, INC. 920 Winter Street waltham, MA 02451 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850020 | Original Filing | |
| S024 | 2006-09-18 | Special (immediate Track) |
| S023 | 2006-04-14 | Special (immediate Track) |
| S022 | 2006-03-31 | Special (immediate Track) |
| S021 | 2005-07-26 | Special (immediate Track) |
| S020 | 2005-07-01 | Normal 180 Day Track No User Fee |
| S019 | 2003-10-17 | Normal 180 Day Track No User Fee |
| S018 | 2003-04-30 | 30-day Notice |
| S017 | 2003-04-15 | Special (immediate Track) |
| S016 | 2002-08-16 | Normal 180 Day Track |
| S015 | 2002-04-15 | 30-day Notice |
| S014 | 2001-08-07 | 30-day Notice |
| S013 | 2001-04-30 | Normal 180 Day Track |
| S012 | 1999-06-21 | Normal 180 Day Track |
| S011 | 1998-07-21 | Panel Track |
| S010 | ||
| S009 | 1997-03-07 | Normal 180 Day Track |
| S008 | 1994-08-12 | Normal 180 Day Track |
| S007 | ||
| S006 | 1993-03-15 | Normal 180 Day Track |
| S005 | 1993-03-09 | Normal 180 Day Track |
| S004 | 1992-02-03 | Normal 180 Day Track |
| S003 | 1990-07-31 | Normal 180 Day Track |
| S002 | ||
| S001 |